Horizon Diagnostics, Inc.: FDA clearances and approvals
Horizon Diagnostics, Inc. has 7 FDA 510(k) clearances (first 1993, latest 1997), across 7 product codes in 1 review panel. Median 510(k) review time: 140 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 1 |
| JFJ | Catalytic Methods, Amylase | 1 | 1 |
| JGJ | Photometric Method, Magnesium | 1 | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 | 1 |
Review panels
Most recent Horizon Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971566 | CREATINE KINASE-MB REAGENT SET | CGS | 1997-07-14 | 76 |
| K933722 | HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT | CDT | 1996-06-13 | 1046 |
| K935712 | IRON/TIBC REAGENT | JIY | 1995-09-20 | 659 |
| K930678 | AMYLASE | JFJ | 1994-04-06 | 421 |
| K934533 | BUN-300/BUN-500 UREA NITROGEN REAGENT | CDQ | 1993-11-26 | 70 |
| K930679 | DIRECT BILIRUBIN | CIG | 1993-06-29 | 140 |
| K930074 | IN-VITRO DIAGNOSTIC REAGENT SET | JGJ | 1993-05-11 | 124 |
Recalls
openFDA lists no recalls under a recalling firm named Horizon Diagnostics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Horizon Diagnostics, Inc. have?
Horizon Diagnostics, Inc. has 7 FDA 510(k) clearances (first 1993, latest 1997), across 7 product codes in 1 review panel.
How long does FDA take to clear Horizon Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Horizon Diagnostics, Inc.'s cleared 510(k)s is 140 days.
What devices does Horizon Diagnostics, Inc. make?
Its most frequent FDA product codes are CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1); CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes, 1).
Has Horizon Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Horizon Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 7 Horizon Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDQ, Horizon Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.